FDA Proposes Tavneos Withdrawal as Amgen Beats Q1 EPS, Raises 2026 Outlook
AMGN sits 30% above its 52-week low of $261.43.
Summary
Amgen reported Q1 adjusted EPS of $5.15, beating analyst estimates of $4.76, and revenue of $8.6 billion, matching estimates, while also slightly raising its full-year 2026 adjusted EPS and revenue guidance. Critically, the U.S. FDA proposed withdrawing approval for its autoimmune drug Tavneos, citing lack of proven effectiveness and false statements, prompting Amgen to submit a label amendment related to liver toxicity. This earnings report follows a recent 8-K filing regarding executive leadership changes and escalates a previously noted "regulatory conflict with the FDA" from the last 10-K into a specific and severe challenge for Tavneos. The mixed Q1 results, with an EPS beat and raised guidance, are positive, driven by strong demand for drugs like Repatha, but the proposed FDA withdrawal for Tavneos introduces substantial regulatory risk and uncertainty for a drug that saw 32% sales growth in Q1. This could significantly impact future revenue from Tavneos and potentially set a precedent, while the miss on Prolia sales due to patent expirations also highlights competitive pressures. Investors will closely monitor Amgen's engagement with the FDA regarding Tavneos and the outcome of the label amendment submission, alongside further updates on the development of the experimental weight-loss drug MariTide.
At the time of this announcement, AMGN was trading at $339.00 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $186.9B. The 52-week trading range was $261.43 to $391.29. This news item was assessed with negative market sentiment and an importance score of 9 out of 10. Source: Reuters.